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Dykema | December 2018

The U.S. Centers for Medicare and Medicaid Services (CMS) has once again stepped up its oversight of Accrediting Organizations (AOs).[1] On December 18, 2018, CMS issued a Request for Information (RFI) seeking to determine whether AOs have a conflict of interest between their governmental contract and their private business. See “Medicare Program: Accrediting Organizations Conflict of Interest and Consulting Services; Request for Information,” 83 FR 65331 ...

Simonsen Vogt Wiig AS | December 2018

PSD2 came into effect in the European Union on January 13, 2018. PSD2 is important as it aims to further harmonise the EU payments market and break the banks' de facto monopoly on the provision of payment services and the use of their customer data. Below is a review of developments to date as they relate to transposing PSD2 into Norwegian law, including an update on the most recent developments ...

Dinsmore & Shohl LLP | December 2018

Beginning January 1, 2019, employers in Illinois will have new requirements for reimbursing employee expenses. An amendment to the Illinois Wage Payment and Collection Act (IWPCA) is the first Illinois law regulating employer reimbursement for employees’ business-related expenditures. Previously, the IWPCA did not address employee reimbursement, so employers were free to implement their own rules and procedures for reimbursing employees for business expenses ...

Most companies go to great lengths to protect and maintain their intellectual property (IP). These companies recognize the value of their IP and work towards its development, sustainability and commercialization. IP strategy customary includes where and when to file patent applications, how to choose a brand name and register it, how to protect and enforce copyrights, protect trade secrets, etc ...

Dykema | December 2018

Beginning on January 1, 2019, Illinois employers will—for the first time—have to reimburse employees for “all necessary expenditures or losses incurred by the employee within the employee’s scope of employment and directly related to services performed for the employer ...

Deacons | December 2018

The Discrimination Legislation (Miscellaneous Amendments) Bill 2018 (Bill) was gazetted on 30 November 2018 ...

Simonsen Vogt Wiig AS | December 2018

The online retail sector has seen a considerable increase in intervention by the competition authorities both on a national level and in Brussels. Most recently, in December 2018, the European Commission fined the clothing company Guess € 39.8 million for applying online sales and advertising restrictions ...

Heuking | December 2018

The ePrivacy Regulation was actually supposed to enter into force on May 25, 2018 jointly with the EU General Data Protection Regulation. Now it is expected to go into effect in 2019 at the earliest. It has new provisions in store, particularly for online marketing. The ePrivacy Regulation is intended to replace the current European ePrivacy Directive (2002/58/EC) and the Cookie Directive (2009/136/EC) ...

Dykema | December 2018

Several years ago the U.S. Centers for Medicare and Medicaid Services (CMS) required skilled nursing facilities (SNFs) to report nurse staffing levels using the SNF’s payroll records, in an effort to obtain more accurate information about actual daily nurse presence in SNFs. CMS has collected this Payroll Based Journal (PBJ) information for a few quarters now ...

Dykema | December 2018

On December 4, 2018, the Michigan Legislature pared back the minimum wage and paid sick leave laws it passed last September in an effort to preclude those issues from being on the November ballot. Had the Legislature not adopted the language of the ballot initiatives legislation, the measures would have been on the November ballot and it would have needed a vote of three-fourths of each house to amend the law if adopted by the voters ...

Heuking | December 2018

I. Introduction According to a Bitkom study from September 2018, German industry has incurred a total loss of 43 billion euros as a result of cyberattacks over the past two years. Seven out of ten industrial companies have been victims of such attacks during this period. At EU level, there has recently been a growing discussion on how to face this mounting danger ...

Dinsmore & Shohl LLP | December 2018

On December 7, 2018, the Food and Drug Administration (FDA) released a Proposed Rule that clarifies procedures and criteria for the de novo medical device clearance pathway.  In a statement accompanying the Proposed Rule, FDA Commissioner Scott Gottlieb stated FDA believes the Proposed Rule will help facilitate classification of innovative low- to moderate-risk novel medical devices by providing more structure, clarity, and transparency to the de novo pathway ...

Dinsmore & Shohl LLP | December 2018

On December 11, 2018, Pennsylvania Auditor General Eugene A. Depasquale released a long-awaited report discussing the role of pharmacy benefit managers (PBMs) in Pennsylvania’s health care system ...

Dykema | December 2018

As an eventful 2018 comes to a close, we look ahead to 2019 and our “Top 10 List” of key issues U.S. financial institutions, non-banks providing financial services, and financial technology (fintech) entities should plan for and watch throughout the upcoming year. The first five items on the list are discussed below, and the remainder of our list will follow shortly in another post ...

Dykema | December 2018

Over the last several years, the emphasis on privacy and data protection has grown significantly. With the amount of data collected by companies and technology skyrocketing, the need to protect personal information has been at the forefront of states’ legislative agendas. While all 50 states now have breach notification statutes, states are now taking a closer look at issues such as tracking online behavior and the use of biometric data ...

Dykema | December 2018

Executives and in-house counsel should be aware that traveling with sensitive data can lead to its seizure—with potentially severe consequences worldwide. Recently, Parliament in the United Kingdom seized from a traveling executive a USB drive containing data that had been produced in a United States lawsuit between Six4Three, a software company, and Facebook. Put simply, that data was in the wrong place at the wrong time ...

Dykema | December 2018

Medicare and Medicaid certified nursing homes are frequently required to pay fines (called “civil money penalties” or “CMPs”) to the U.S. Centers for Medicare and Medicaid Services (“CMS”) when government surveyors find them out of compliance with the Requirements for Participation for Long-Term Care Facilities. It is not uncommon for CMS to assess CMPs in the hundreds of thousands of dollars ...

Hanson Bridgett LLP | December 2018

Under the Affordable Care Act (“ACA”), large employers (generally those with 50 or more full-time employees or full-time equivalents) must report annually to the IRS information about the health coverage offered to their full-time employees during the prior year using IRS Form 1095-C. The IRS uses the forms to assess whether an employer "shared responsibility" penalty applies. Employers also must provide copies of the forms to their full-time employees ...

Dykema | December 2018

Increased federal oversight may be on the horizon for skilled nursing facility involuntary transfers and discharges. The Office of Inspector General (OIG) included in its 2019 Work Plan reviewing SNFs’ involuntary transfers and discharges, focusing on reviewing whether State agencies have effectively investigated and enforced proper transfer and discharge procedures ...

Dinsmore & Shohl LLP | December 2018

Often, board of education members believe what happens in executive session, stays in executive session. However, you and your board’s members, both new and old, are well-served to remember that many issues, including those involving personnel, discussed in executive session are communications that may be subject to discovery in a deposition or other legal proceeding by an affected employee ...

Simonsen Vogt Wiig AS | December 2018

Regulation (EU) 2018/302 of February 28, 2018, on addressing geo-blocking and other forms of discrimination based on customers' nationality, place of residence or place of establishment within the internal market (the "Regulation") came into force, December 3, 2018. The Regulation seeks to increase access for customers in the EU and EEA to goods and services by preventing unjustified geo-discrimination due to the customer's nationality, place of residence or establishment ...

Dykema | December 2018

In February of this year, the Securities Exchange Commission issued its updated Statement and Guidance on Public Company Cybersecurity Disclosures. In April, the SEC issued an Order that, among other things, levied a $35 million fine against Yahoo! Inc. for failing to properly report a 2014 data breach. These actions support the view that the SEC is consciously committing attention and resources to cybersecurity issues affecting public companies ...

Dykema | December 2018

As in previous years, the California legislature kept busy in 2018. As a result, a number of new and noteworthy employment laws will go into effect on January 1, 2019, and beyond. Much of the legislation stems from the #MeToo movement by strengthening harassment and discrimination protection, imposing broader anti-harassment training obligations, updating lactation accommodations and mandating female presence on boards of public companies ...

Dinsmore & Shohl LLP | November 2018

The deadline for meeting the previously issued nursing home compliance mandate is approaching. The Centers for Medicare & Medicaid Services (CMS) issued the mandate in 2016 and gave facilities three years to become compliant. On November 28, 2019, skilled nursing facilities (SNF) and nursing homes will be required to adopt and implement a compliance program as a condition for participation in Medicare and Medicaid ...

Heuking | November 2018

Since the GDPR has been in force, almost every company has, among other things, dealt with issues of the permissibility of direct marketing and other marketing activities under data protection law. At their data protection conference on Nov. 07-08, 2018, the German data protection supervisory authorities issued a new "orientation guide" on this topic (as of November 2018) ...

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